Elutia has been recognized with the Innovation and Product Launches awards in the 2025 Medical Device Network Excellence Awards for its advancements in drug eluting bioenvelopes and implantable device adjuncts. The company’s achievements in device protection and patient care for cardiac and neurostimulation procedures were key reasons behind the award win, with a focus on its flagship product, EluPro® Antibiotic-Eluting BioEnvelope.
The Medical Device Network Excellence Awards honor the most significant achievements and innovations in the medical devices industry. Powered by GlobalData’s business intelligence, the Awards recognize the people and companies leading positive change and shaping the future of the industry.
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Elutia won the Innovation award for its pioneering advancements in drug eluting bioenvelopes that address key challenges in device protection and healing. The company received the Product Launches award for successfully introducing a novel implantable device adjunct, EluPro, that has rapidly gained clinical and commercial traction in the market.
Innovation in drug eluting bioenvelopes: Advancing device protection
Elutia’s recognition in the drug eluting bioenvelopes category is rooted in its development of the world’s first FDA-cleared drug eluting bioenvelope that combines regenerative biomatrix technology with local antibiotic delivery. This innovation directly addresses a persistent challenge in the field of implantable devices: the need to provide robust antimicrobial protection without sacrificing the body’s natural healing processes.
Historically, device protection solutions have required clinicians to choose between synthetic, antimicrobial materials—which can impede tissue integration and provoke inflammatory responses—and biologic materials that support healing but lack infection prevention capabilities. Elupro, Elutia’s drug eluting bioenvelope, eliminates this trade-off by integrating a natural extracellular matrix (ECM) derived from regenerative biomaterials with a dual antibiotic delivery system. The ECM supports the formation of healthy, vascularized tissue around the implant, while the embedded antibiotics—rifampin and minocycline—provide broad-spectrum protection against pathogens commonly associated with device-related infections.
This dual-action approach is significant for several reasons. First, it supports natural tissue remodeling, reducing the risk of fibrosis and chronic inflammation that can complicate device implantation and revision procedures. Second, the local, sustained release of antibiotics at the surgical site targets the period of highest infection risk, without exposing patients to the side effects of systemic antibiotic therapy.
Elutia’s innovation is further distinguished by its potential as a platform technology. The drug eluting bioenvelope’s design can be adapted for a range of implantable devices, paving the way for future adjuncts that combine regenerative and antimicrobial properties. The company has substantiated its claims with robust preclinical and laboratory data, including published studies demonstrating the envelope’s ability to eradicate bacterial colonization and promote tissue regeneration. For example, animal model studies published in peer-reviewed journals have shown that the drug eluting bioenvelope not only reduces infection rates but also facilitates the development of healthy, vascularized tissue around the implant, which is critical for long-term device stability and patient outcomes.
By addressing a critical unmet need and validating its efficacy through scientific evidence, Elutia has set a new benchmark in the field of device protection, which was a key factor in its recognition for innovation.
Launch of EluPro and the evolution of implantable device adjuncts
Elutia’s recognition in Product Launches for Implantable Device Adjuncts is anchored by the successful commercial introduction of EluPro, the world’s first antibiotic-eluting bioenvelope. Launched in the United States in January 2025, EluPro was developed to address the significant risks and costs associated with infections following the implantation of cardiac and neurostimulation devices. With over 600,000 cardiac implantable electronic devices (CIEDs) placed annually in the U.S. and complication rates of 5-7%, the need for improved adjunctive protection is clear.
EluPro’s design is notable for its combination of a natural ECM biomatrix and a dual antibiotic delivery system. The ECM is engineered to conform naturally to the shape of the device, providing a soft, biocompatible interface that supports tissue integration and device stability. The embedded bioabsorbable polymer disc delivers rifampin and minocycline directly to the surgical pocket, providing extended local antibiotic coverage during the critical post-implantation period. This approach is intended to reduce the risk of bacterial colonization and subsequent infection, which can lead to severe complications, prolonged hospital stays, and increased healthcare costs.
The product’s ease of use is also a key differentiator. EluPro is designed for straightforward integration into existing surgical workflows: it is hydrated, the device is inserted, and the pliable and conforming envelope is secured with a single stitch before implantation. This simplicity has contributed to its rapid adoption among clinicians, as evidenced by its integration into procedures across all major CIED brands and its expanding use in neurostimulation markets.
Commercially, EluPro has demonstrated strong performance since its pilot launch in September 2024. In its first full quarter on the market, EluPro sales increased 84% sequentially, driving a 31% year-over-year revenue increase in Elutia’s BioEnvelope segment. The company has achieved approvals from 150 hospital value analysis committees and established partnerships with seven major group purchasing organizations, including Advantus Health Partners, Premier, Inc. and Southern Strategic Sourcing Partners (S3P). These milestones reflect both the clinical demand for the product and its acceptance within the healthcare procurement ecosystem.
EluPro’s impact extends beyond infection prevention. By supporting tissue healing and reducing foreign body response, the product helps create a stable pocket environment for the device, potentially reducing complications such as device migration or erosion. Clinical studies have shown that the use of bioenvelopes can make reoperations less difficult and reduce lead adhesions, which are important considerations for long-term patient management.
Furthermore, EluPro’s clearance for use with neurostimulators and neuromodulators—devices used in the management of pain, movement disorders, epilepsy, incontinence, and sleep apnea—positions it to address a global market opportunity estimated at $8 billion. As the first in a planned pipeline of drug-eluting biologics, EluPro establishes Elutia as an early leader in the emerging category of implantable device adjuncts that combine regenerative and antimicrobial technologies.
The combination of clinical impact, commercial traction, and platform potential were central to Elutia’s recognition in the Product Launches category.
“We’re honored to receive recognition from Medical Device Network in both the Innovation and Product Launches categories. These awards reflect the work of two exceptional groups at Elutia: our scientists and our go-to-market team. But the truth is that neither could have succeeded in isolation. This effort is the embodiment of our CRU values, from concept to commercialization. It’s how we work here, and it’s why EluPro is successful.” – Dr. Randy Mills, President & CEO of Elutia
Company Profile
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.
Contact Details
Courtney Guyer, VP Marketing
Phone: 240-247-1170
E-mail: cguyer@elutia.com
Links
Website: www.elutia.com
http://elutia.com/feelthedifference
